The FDA’s Food Safety Modernization Act mandates both domestic and foreign food facilities that are required to register with Section 415 of the Food, Drug, & Cosmetic Act must also comply with the requirements for risk-based preventive controls. Accordingly, food manufacturers must validate (21 CFR § 117.160) that the preventive controls implemented, such as baking, cooking, extrusion, etc., are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system. The main purpose of this step is to assure safety of the final finished food products and protect consumers from potential foodborne illnesses.

The most common path of accomplishing validation requirement is through a product-specific microbial challenge study. Properly executed, this involves inoculating a pathogen or surrogate microorganism that has similar resistance properties to the pathogen into a food or formulation to scientifically simulate the effect of baking process parameters (e.g., heat and time) during a kill-step. A scientific understanding of the product-specific thermal process step on potential microbial hazards is then critical to assure the safety of the finished product. In short, a scientific validation study helps determine whether a particular baking kill-step process has the ability to destroy the pathogen of concern.

Generally, a product-specific microbial validation study can cost upward of $20,000 and may take up to three to four months. These barriers to completing a validation study can increase depending on the type of food product, complexity of the kill-step process, and pathogens of concern. This is an immense burden on small and medium-scale bakeries. In order to help baking companies around the world, AIB International took a leadership role and partnered with industry stakeholders and various state universities to conduct baking thermal process kill-step validation studies for a variety of bakery products.

Since 2014, AIB International has completed development of 10 product-specific baking validation studies. The products have included hamburger buns, 100 percent whole-wheat breads, plain muffins, nut muffins, crisp cookies, soft cookies, doughnuts, tortillas, cheesecake, fruit-filled pastries, and peanut butter bars. Additionally, we have developed product-specific KSV calculators for each of these products based on the thermal-resistance characteristics of Salmonella.

Each of these KSV calculators can be downloaded for free in both degree Fahrenheit (˚F) as well as degree Celsius (˚C) versions and includes complete instructions. These calculators work by using product-specific baking times and core temperature parameters to automatically calculate the total baking process lethality for Salmonella cells in terms of log reduction.

Additionally, the calculator generates a product-specific KSV report. If the desired log reduction for Salmonella is achieved for the specific baking process, then the KSV report can be used to comply with the validation requirement. This novel approach helps bakers meet the FDA validation requirement without investing in expensive and time-consuming microbial validation studies.

The validation of a thermally processed kill-step plays an important role in complying with FDA’s regulatory requirement and/or established standard industry specifications. It also protects public health by safeguarding consumers from possible foodborne illnesses, while further building consumer confidence in our ability to continue producing safe, high-quality baked goods, which will help drive consumer demand for these products.